Retrospective Trial on the Efficacy and Safety of Intravitreal Ozurdex in Patients With Diabetic Macular Edema.

A Collaborative Retrospective Trial on the Efficacy and Safety of Intravitreal Dexamethasone Implant (Ozurdex) in Patients With Diabetic Macular Edema (DME). THE EUROPEAN DME REGISTRAR STUDY (ARTES)

To review the safety and efficacy of injections with Ozurdex (700 μg dexamethasone) in clinical practice management of patients with DME.

Inclusion Criteria:

• Adults (≥18 years) with diabetes
• DME in the study eye (if both eyes have DME both eyes will be included in analysis)
• BCVA minimum of 20/200 (35 letters)
• Central Macular Thickness (CMT) ≥300 µm
• Patients with DME who were treated with Ozurdex at least twice (baseline is before the first Ozurdex injection).
• Follow up of at least 6 months after the last Ozurdex injection given
• Complete records including BCVA (OCT and Fluorescein Angiography (FA) if available) throughout the follow up

Exclusion Criteria:

• Patients with ME not secondary to Diabetes Mellitus (DM).
• Presence of other retinopathies (AMD, RVO) or visually significant ocular morbidity (e.g. advanced glaucoma, corneal opacity)
• Previous ocular trauma or surgery other than cataract extraction
• Intravitreal triamcinolone ≤6 months before baseline
• Intravitreal bevacizumab, ranibizumab, or pegaptanib <1 months before baseline
• Marked intraocular pressure (IOP) elevation in response to any previous steroid treatment
• Ocular Hypertension (OHT) in the study eye(s)
• IOP >23 mm Hg without antiglaucoma medication
• IOP >21 mm Hg with one antiglaucoma medication
• Use of 2 or more antiglaucoma medications
• Glaucoma - Visual Fields (VF) defect > 4 dB